Regulating Emotions Like An eXpert Among Adolescents With ADHD

Part of paid clinical trials in Blacksburg, Virginia.

Sponsor
Virginia Polytechnic Institute and State University
Study ID
NCT06725186
Status
Recruiting

Conditions

  • EMI Smartphone App Pilot
  • Psychoeducational Waitlist Control
  • RELAX Telehealth Intervention

Eligibility Criteria

Sex
ALL
Age
11 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • RELAX — BEHAVIORAL
    The RELAX intervention is a social-emotional intervention consisting of 8 weekly, 1.5 hr sessions and a booster session 1 month and 6 months after the completion of RELAX. During the first 60 minutes of RELAX sessions, parents and adolescents meet separately; during the last 30 minutes combined parent-adolescent discussion and problem-solving activities take place. RELAX is structured such that parents learn emotion regulation/coping skills the week prior to them being taught to the adolescents. Group sessions will involve both didactics and discussion of topics including psychoeducation, basic cognitive/behavioral principles, emotional awareness, emotion regulation strategies, parent emotion socialization practices, coping skills, conflict management strategies, and communication skills.
  • Psychoeducational Materials — BEHAVIORAL
    Infographics with information on emotion regulation development, emotion regulation strategies, and strategies for managing interpersonal conflict, including when different strategies are more or less effective will be provided to participants via email.

Study Details

This study consists of a randomized controlled trial assessing the acceptability, feasibility, and efficacy of the RELAX (Regulating Emotions Like An eXpert) Intervention. Following randomization, 30 families will receive the RELAX intervention and 30 families will receive psychoeducational materials as part of a control condition. Additionally, 10 families from the RELAX condition will participate in a pilot study and focus groups to give feedback on developed smartphone apps to support skill use during and following completion of RELAX.

Key Dates

Start date
Jan 15, 2025
Status verified
Jan 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RELAX Intervention
    group-based RELAX telehealth intervention
  • Active Comparator: Psychoeducational Waitlist Control
    The psychoeducational component will consist of infographics regarding emotion regulation strategies and managing interpersonal conflict.

Primary Outcome Measure

Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) [ Time Frame: From enrollment to the 6-month follow-up period. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Child Study CenterBlacksburgVirginia24060
Rosanna Breaux, PhD
540-231-8276

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